N/A
N=26
Investigating Transcranial Ultrasound as a Potential Intervention for Depression
Depression · Anxiety Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02685488 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Depressive Symptoms Assessed With the Beck Depression Inventory-II — -4.42; -.650 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial Ultrasound Power (Device); Transcranial Ultrasound Sham (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Arizona
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depressive Symptoms Assessed With the Beck Depression Inventory-II |
-4.42; -.650 | — |
| SECONDARY Rumination Symptoms Assessed With the Ruminative Responses Scale |
-1.83; -2.10 | — |
| SECONDARY Worry Symptoms Assessed With the Penn State Worry Questionnaire |
-1.83; 3.30 | — |
| SECONDARY Anxiety Symptoms Assessed With the Overall Anxiety Severity and Impairment Scale |
-1.33; -2.50 | — |
Summary
Depression is the leading cause of disability worldwide. Because a significant number of people with depression do not respond to medication or therapy, alternative treatment options are greatly needed. Recent research has focused on brain stimulation methods due to their therapeutic utility for treating depression. Yet, current brain stimulation methods have drawbacks, including invasive surgery and limited precision in targeting specific areas. A novel brain stimulation method, transcranial ultrasound (TUS), is noninvasive, has greater spatial precision than most existing methods, and is proven safe for humans. TUS has been found to increase positive mood in chronic pain patients. In a double blind study, TUS increased positive mood in over 140 healthy undergraduates at the University of Arizona.
Despite evidence that TUS can increase positive mood in humans, it has yet to be investigated whether TUS can increase positive mood in humans who are experiencing chronic low mood or depression. The present study will, for the first time, examine whether TUS can improve depressive symptoms. Twenty to thirty participants with mild to moderate depressive symptoms (Beck Depression Inventory Score between 10 and 25) will be randomly assigned to a TUS sham or TUS activation condition. In the TUS activation condition, TUS will be used to stimulate the right fronto-temporal area, which has previously been shown to increase positive mood. Participants in the TUS sham condition will not receive any brain stimulation. Participants will attend five sessions within seven days or ten sessions within fourteen days. At each session, in addition to brain stimulation, self-reported mood and depressive symptoms will be recorded. Furthermore, the investigators will use electroencephalogram (EEG) to record changes in brain electrical signals during TUS stimulation. Based on prior research, the investigators predict that mood will increase and depressive symptoms will decrease with TUS stimulation.
Eligibility Criteria
Inclusion Criteria
- Beck Depression Inventory score between 10 and 25
Exclusion Criteria
- left-handedness
- prior serious head-related injury
- any medical condition that would impact EEG profiles
- chronic migraines or other severe headaches
- pregnancy
- lack of proficiency in English
- lack of secure housing
- current confounding treatment (including any psychotropic medication or psychotherapy)
- current active suicidal potential necessitating immediate treatment, as such participants will be referred for immediate treatment.
Data sourced from ClinicalTrials.gov (NCT02685488). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.